(72 days)
Not Found
No
The document describes "computer-assisted cell counting and cell analysis capabilities" and "classifiers" used in performance testing, but does not explicitly mention AI or ML technologies. The analysis methods described appear to be based on traditional image processing and statistical analysis rather than AI/ML algorithms.
No
The device is used for examination and measurement, which are diagnostic functions, not therapeutic ones.
Yes
The device is intended for "examination of the corneal endothelium and for measurement of the thickness of the cornea," which are diagnostic activities. It also includes "Cell counting and analysis programs...to allow for analysis of the cell distribution of the eye." This analysis provides information used for diagnosis.
No
The device description clearly indicates it is a physical ophthalmic microscope, optical pachymeter, and camera with hardware components like a CCD camera, touch screen, forehead rest, and chin rest, in addition to the software for analysis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the examination of the corneal endothelium and measurement of corneal thickness. This is a direct examination of a living patient's tissue using optical methods.
- Device Description: The device is a non-contact ophthalmic microscope, optical pachymeter, and camera. It captures images of the eye and performs analysis on those images. It does not involve testing samples of biological material in vitro (outside the body).
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring or compatibility purposes. This device does not fit this definition.
While the device performs analysis on images and provides data that can be used in a diagnostic process, the analysis is performed on images captured directly from the patient's eye, not on a biological specimen removed from the body.
N/A
Intended Use / Indications for Use
The Konan Specular Microscope XIV, Cellchek Plus, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.
Product codes
NQE
Device Description
The Konan Specular Microscope XIV, CellChek Plus, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. Cell counting and analysis programs are included, and allow for analysis of the cell distribution of the eye (the same analysis software present in the predicate device is also present in the modified device).
When photographing the corneal endothelium, the equipment performs the alignment and automatically focuses by capturing the reflected light from the patient's eye with the CCD camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory, and are preserved by using a printer.
Both the image of the corneal endothelium and the various computerized control functions are displayed on the touch screen.
The parts of the device that come into contact with a patient are the forehead rest and the chin rest. The head rest is comprised of Polytetrafluoroethylene (PTFE), which is known as Teflon®, and the material that comprises the chin rest is Acrylonitrile butadiene styrene (ABS).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Corneal endothelium, cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A Clinical test was performed with four "classifiers", each analyzing the same 40 images of eyes by using the Konan predicate device Noncon Robo Pachy F&A non-contact specular microscope. Each classifier analyzed each image three times. The analyses of the classifiers were analyzed for cell density, hexagonality, and coefficient of variation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non Clinical Tests
- The modified CELLCHEK PLUS device was subjected to electrical safety testing in accordance with IEC 60601-1.
- The modified CELLCHEK PLUS device was subjected to electromagnetic compatibility (EMC) testing in accordance with IEC 60601-1-2.
- The modified CELLCHEK PLUS device was subjected to performance testing, including optical radiation safety testing in accordance with ISO 15004-1 and 15004-2.
- The modified CELLCHEK PLUS device was subjected to software validation testing in accordance with IEC 60601-1-4.
Clinical Tests
A Clinical test was performed with four "classifiers", each analyzing the same 40 images of eyes by using the Konan predicate device Noncon Robo Pachy F&A non-contact specular microscope. Each classifier analyzed each image three times. The analyses of the classifiers were analyzed for cell density, hexagonality, and coefficient of variation.
Agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with Percent Hexagonality 0.41, or Cell Density
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
APR 1 1 2012
510(K) SUMMARY
11.1 SUBMITTER INFORMATION
| A. | Company Name: | Konan Medical, Inc. |
|---|---|---|
| B. | Company Address: | 10-29, Miyanishicho, Nishinomiya |
| Hyogo 662-0976, Japan | ||
| C. | Company Phone: | +81-798-36-3456 |
| D. | Company Facsimile: | +81-798-26-1028 |
| E. | Contact Person: | Tatsuya Kasahara |
| F. | Date Summary Prepared: | January 24, 2012 |
11.2 DEVICE IDENTIFICATION
| A. | Device Trade Name: | Konan Specular Microscope XIV, Cellchek Plus |
|---|---|---|
| B. | Common Name: | Specular Microscope |
| C. | Classification Name(s): | AC-powered Slit Lamp Biomicroscope |
| D. | Classification Regulation(s): | 886.1850 |
| E. | Device Class: | Class 2 |
| F. | Product Codes: | NQE |
| G. | Advisory Panel: | Ophthalmic |
11.3 IDENTIFICATION OF PREDICATE DEVICE
The predicate device is the Konan Medical, Inc. Noncon Robo Pachy F&A non-contact specular microscope, which was cleared by FDA under 510(k) number K062763 on February 22, 2008.
11.4 DEVICE DESCRIPTION
The Konan Specular Microscope XIV, CellChek Plus, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. Cell counting and analysis programs are included, and allow for analysis of the cell distribution of the eye (the same analysis software present in the predicate device is also present in the modified device).
Konan Medical, Inc.
Confidential
1
When photographing the corneal endothelium, the equipment performs the alignment and automatically focuses by capturing the reflected light from the patient's eye with the CCD camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory, and are preserved by using a printer.
Both the image of the corneal endothelium and the various computerized control functions are displayed on the touch screen.
The parts of the device that come into contact with a patient are the forehead rest and the chin rest. The head rest is comprised of Polytetrafluoroethylene (PTFE), which is known as Teflon®, and the material that comprises the chin rest is Acrylonitrile butadiene styrene (ABS).
11.5 INDICATIONS FOR USE
The Konan Specular Microscope XIV, Cellchek Plus, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.
11.6 TECHNOLOGICAL CHARACTERISTICS
The Konan Specular Microscope XIV, Cellchek Plus is technically equivalent to the Konan Noncon Robo Pachy F&A non-contact specular microscope. The principal design modification for the device is that the mechanical unit used for alignment has been changed. The modified mechanical unit now consists of five axes (the predicate device had 3 axes) and the optical unit can be placed in any position over the cornea to obtain an image of endothelial cells. A smaller computer mother board was implemented, and a new computer program was installed for the modified mechanical system. The system now operates by means of a touch screen.
11.7 SUMMARY OF TESTING
Non Clinical Tests A.
The following testing was performed on the Konan Specular Microscope XIV, Cellchek Plus:
- The modified CELLCHEK PLUS device was subjected to electrical safety testing . in accordance with IEC 60601-1.
2
- The modified CELLCHEK PLUS device was subjected to electromagnetic compatibility (EMC) testing in accordance with IEC 60601-1-2.
- . The modified CELLCHEK PLUS device was subjected to performance testing, including optical radiation safety testing in accordance with ISO 15004-1 and 15004-2.
- The modified CELLCHEK PLUS device was subjected to software validation . testing in accordance with IEC 60601-1-4.
B. Clinical Tests
A Clinical test was performed with four "classifiers", each analyzing the same 40 images of eyes by using the Konan predicate device Noncon Robo Pachy F&A noncontact specular microscope. Each classifier analyzed each image three times. The analyses of the classifiers were analyzed for cell density, hexagonality, and coefficient of variation.
Agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with Percent Hexagonality 0.41, or Cell Density